再生元谈LIBTAYO：吾有上将潘凤 / 四六文摘

Regeneron Pharmaceuticals, Inc. (REGN) Presents atCowen Health Care Broker Conference Call (Transcript)

Company Participants

Jay Markowitz - SVP, Portfolio Management

Robert Landry - EVP, Finance & CFO

Conference Call Participants

Yaron Werber - Cowen and Company

为了节约空间，只截取了和LIBTAYO (cemiplimab-rwlc) 相关的。

Yaron Werber

Yes. So let's - I was going to - any otherquestions? Any questions from the audience? And if not, we're going to shiftover to Libtayo and maybe talk about some of the oncology assets in the nextfew minutes. And then specifically, Libtayo for lung cancer. Give us a little bit of a sense. I know that recently, with some of the recent data between KEYTRUDA and OPDIVO, you have amended some of your studies, sized them up,changed some of the arms or - and discontented, I believe, a couple of earlier studies. When you think about Libtayo, and I know you're also testing now two different dosing schemes. Would it be - what's the strategy? And how - where is the - how do you think about differentiation really over KEYTRUDA, I would say?

比如你们为啥改一线治疗肺癌的方案，去年11月是这样的

今年JPM开始至今就是这样了

包括加大了样本量、改了一些实验组还有终止了一些，另外你们也测试了两个不同的剂量，请问具体怎么看和KEYTRUDA的差异？

JayMarkowitz

Well, let me just correct one thing. And I'llcorrect it by just very - giving a very simple summary of our development plan in lung cancer. So the first is monotherapy against chemotherapy therapy in the PD-L1 high population. So this is like Merck's KEYNOTE-024 and 042. When the KEYNOTE-024 came out, there was one view. And when the KEYNOTE-042 data came out, there was another view. Same drug, supposedly similar. Same population but different data. And we then decided to be on the safe side, we should power the trial for a KEYNOTE-042-like result, which was why we increased the size of that trial. The second trial, looking at all of the data, both combinations with CTLA-4 blockers plus PD-1 or PD-L1 blockers versus combinations of PD-1 blockers with chemotherapy, we amended that trial. So it's quite simply Libtayo plus chemotherapy versus chemotherapy. Sort of like the KEYNOTE-189 trial.That, in a nut shell, is our cancer strategy with Libtayo - lung cancer strategy with Libtayo.

我来纠正一下，简单的总结我们的肺癌开发计划。首先是在PD-L1高表达群体中单药对比化疗，就像KN024和KN042(的高表达组)，024出来一个观点，042出来又是一个观点，相同的人群不同的数据。为了保险，我们假设做出像042那样的结果所以加大了样本量。

第二个研究中我们看了所有的CTLA4+PD-1或者PD-L1+化疗和PD-1+化疗的比较，就做了改变，就是简单的Libtayo+化疗，通俗易懂，像KN189那样按PD-L1分层。

YaronWerber

Okay. So is the thought that this is going to be sizable market, Libtayo potentially is third or fourth to market in this segment and with potentially better data? Or is it a...

在这个市场不还是第三个第四个嘛…

JayMarkowitz

So how many - okay, think about what you just said, Yaron. How many drugs are approved as monotherapy in the first-line metastatic lung cancer?

想想你提的那个问题吧，现在获批的那些又有多少个是单药一线治疗NSCLC的？

YaronWerber

So this is really - you're talking about really the head-to-head against chemo as the corner stone?

你是在说单药对比化疗？

JayMarkowitz

Well, we have the potential to be the second,right? Right now it's only KEYTRUDA has that approval, right? And if you look at some of these others, whether it's OPDIVO or the PD-L1 blockers, it justseems like they have not generated the kind of data that KEYTRUDA has. So we think that we have the potential, again, depending on how our trials read out,to be the second drug. And then if you just simply look across trial comparisons either in our Phase I monotherapy data in lung cancer or if you look at other drugs that - other similar drugs that have been tested in cutaneous squamous cell carcinoma, you stack up our numbers against their numbers, we feel that Libtayo has a competitive profile.

我们很可能是第二个，不是吗？现在不还是只有KEYTRUDA获批嘛，你看OPDIVO 或者PD-L1都没KEYTRUDA这样的呆塔，所以我们有这个潜力，另外你们只要比较下我们的一期肺癌单药数据，或者看下其它类似药物在CSCC中的数据，把我们的数字和其他的比一下，我觉得还是有竞争力的。

【我就讲三句话】在下书念得少，始终没get到之前方案和Keyturda头对头的自信在哪里：PDL1 high群体的ORR是高，可这三个人的样本和默大先生家两个临床四百人的样本怎么比，update的计划中和Keytruda的头对头研究没有了，这个算明智的选择。未来极可能就是the second chemo free regimen in PD-L1 high population，另外完全可以等对比chemo的做完了再根据呆塔再徐图进取嘛